BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DETERMINE HIV-1/2 AG/AB COMBO 25T

    MDR report key: 21588125 · Received March 12, 2025

    Report

    Report Number
    1221359-2025-00097
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    March 4, 2025
    Report Date
    September 22, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP120037
    Removal / Correction Number
    1221359-07/31/2025-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 0000930922 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 7D2648/ LOT 0000930922, DEVICE PART NUMBER 10732998/ LOT 943284. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 0000930922 SHOWED THAT THE COMPLAINT RATE IS (B)(4). AS PART OF AN INVESTIGATION INTO PRELIMINARY FALSE REACTIVE RESULTS, ABBOTT FOUND THAT FOR KIT LOT 0000930922, THE ROOT CAUSE OF THE RESULTS WAS DUE TO A SUBCOMPONENT USED IN THE MANUFACTURE OF DETERMINE HIV-1/2 AG/AG COMBO. THE ISSUE HAS BEEN ISOLATED TO SPECIFIC LOTS OF THE SUBCOMPONENT, WHICH WERE USED TO MANUFACTURE SPECIFIC TEST KIT LOTS. THE NECESSARY ACTIONS TO PREVENT RECURRENCE HAVE BEEN TAKEN, AND THE CORRECTION OF PRODUCT IN THE FIELD WAS CONDUCTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TEN (10) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON VARIOUS DATES. THIS REPORT ADDRESSES TEST TEN (10) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON (B)(6) 2025 WITH AN EDTA PLASMA SAMPLE. A CONFIRMATORY METHOD (DATE PERFORMED AND BRAND UNKNOWN) WAS USED TO TEST A SEPARATE EDTA PLASMA SAMPLE FROM THE SAME PATIENT, WHICH RETURNED A NEGATIVE RESULT. NO PATIENT INFORMATION WAS PROVIDED; HOWEVER, IT IS UNDERSTOOD THAT THE PATIENTS ARE OB/GYN PATIENTS. NO OTHER INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TEN (10) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON VARIOUS DATES. THIS REPORT ADDRESSES TEST TEN (10) OF TEN (10). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON (B)(6) 2025 WITH AN EDTA PLASMA SAMPLE. A CONFIRMATORY METHOD (DATE PERFORMED AND BRAND UNKNOWN) WAS USED TO TEST A SEPARATE EDTA PLASMA SAMPLE FROM THE SAME PATIENT, WHICH RETURNED A NEGATIVE RESULT. NO PATIENT INFORMATION WAS PROVIDED; HOWEVER, IT IS UNDERSTOOD THAT THE PATIENTS ARE OB/GYN PATIENTS. NO OTHER INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111948 DETERMINE HIV-1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 0000930922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown